Transcutaneous Spinal Cord Stimulation in Children With Incomplete Spinal Cord Injury Safety, Feasibility, and Efficacy

What this Trial Is About

Researchers are evaluating the safety, feasibility, and effects of transcutaneous spinal cord stimulation TSCS combined with gait training in children aged 3 to 16 years with incomplete spinal cord injury iSCI. The study aims to compare TSCS with sham stimulation to see if TSCS is safe, feasible, and can improve muscle activity and walking ability. The trial also explores how TSCS affects muscle strength within a single session and over an eight-week training period. Participants are randomly assigned to either the experimental group receiving TSCS or a control group receiving sham stimulation. Both groups will undergo eight weeks of individualized gait training, consisting of 24 sessions with treadmill training, strengthening exercises, and gait-based tasks. TSCS involves applying a small electrical current through electrodes placed on the back and lower abdomen for 30 minutes, while sham stimulation uses similar electrode placement but with brief stimulation only. Throughout the study, participants will be assessed using clinical tests like the Timed Up and Go, 10-Meter Walk Test, Walking Index for Spinal Cord Injury II, and 6-Minute Walk Test. Researchers will monitor safety by recording any adverse events such as pain or skin irritation, and measure muscle activity using surface electromyography and dynamometry. Sessions occur multiple times per week over 5 to 8 weeks, with evaluations at several time points to track changes in walking function and muscle strength.

Transcutaneous Spinal Cord Stimulation in Children With Incomplete Spinal Cord Injury